A Phase II Trial to Evaluate the Use of Trental and Vitamin E for Prophylaxis of Radiation Necrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Number of Participants With Symptomatic Radiation Necrosis
研究概览
简要总结
The purpose of this study is to determine whether the use of Trental and Vitamin E can help reduce the incidence of radiation necrosis (a lesion that usually occurs at the original tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis when it occurs but the hope is that these drugs can be used to prevent radiation necrosis from ever occurring.
详细描述
The treatment phase of the study is 6 months. Study procedures will be conducted such as: history, physical and neurological exam, pregnancy testing (for women of child bearing age) and a Brain MRI. Follow-up appointments will be every 3 months for 1 year at which time, your participation in the study will be concluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Plan to undergo single or five fraction radiosurgery for a metastatic brain tumor
- •Diagnosis of a metastatic brain tumor may be accomplished by histologic confirmation or by clinical confirmation by the treating physician based on MR imaging characteristics in the setting of a known history of cancer
- •Age > 18 years
- •Partial or total resection of a metastatic tumor are eligible
排除标准
- •Known sensitivity to vitamin E or Trental
- •Recent intracranial bleed or retinal hemorrhage
- •Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
- •History of Avastin treatment
- •Anticipated need for treatment with Avastin
- •History of bleeding disorder
- •History of liver disorder
研究组 & 干预措施
Trental + Vitamin E
Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment
干预措施: Trental (Drug)
Trental + Vitamin E
Trental 400 mg TID and Vitamin E 400IU BID starting the first day after the last radiosurgery treatment
干预措施: Vitamin E (Dietary Supplement)
结局指标
主要结局
Number of Participants With Symptomatic Radiation Necrosis
时间窗: average 1 year
Number of symptomatic death of healthy tissue caused by radiation therapy.
次要结局
未报告次要终点
研究者
Michelle Marcum
Director, University of Cincinnati Cancer Center
University of Cincinnati